Summarize the primary purpose & key accountabilities of the job.
- Primary responsible for liaising with Clinical Development project team members, and specifically with the Clinical Pharmacology Lead, to contribute to clinical study protocols, statistical analysis plans, reporting plans, and delivery of non-compartmental analyses (NCA) and contributions to the Clinical Study Report for Clinical Pharmacology studies.
- May help provide support and/or development of quantitative methodology and best practices, pharmacometrics tools, software, hardware, and related business processes.
Indicate the primary responsibilities critical to the job.
- Responsible for the planning and execution of relevant pharmacokinetic, primarily but not limited to, non-compartmental analyses (NCA) which may include pharmacokinetics and pharmacodynamics studies in collaboration with partners.
- Prepares interpretation, preparation, and review of pharmacokinetic contribution to clinical and written study reports to Pfizer standards.
- May provide Quantitative Clinical Pharmacology expertise on multidisciplinary development teams, working closely with clinical pharmacologists, clinicians and statisticians to to provide pharmacokinetic analyses.
- May contribute with project teams/partners to investigators brochures, clinical pharmacology summaries, manuscripts, and regulatory documents.
- Stays abreast of literature, government guidelines, and internal guidance as relates to pharmacokinetic analysis, including internal SOPs and regulations in order to be a team resource of pharmacometric knowledge and applications.
- May contribute to the development or improvement of our tools, processes and methodology, including involvement in internal cross-functional workgroups or initiatives, external alliances or committees, consortia and academic relationships.
Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.
- B.S. with 2-4 years of experience in quantitative data analysis, or M.S. with 0-2 years of experience in quantitative data analysis
- Experience using WinNonLin, Phoenix, Kinetica, or equivalent
- Good communication skills (written, oral presentation)
- Other statistical software experience (e.g. R)
- Other relevant software experience (e.g. Microsoft Excel and Word)
- We encourage applicants from different disciplines including clinical pharmacology, engineering, biostatistics, medicine, biology, etc.
Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities. Include any external interactions as appropriate.
- Reports to Pharmacometrics Group Leader within the line organization of Pharmacometrics, GPD-Clinical Pharmacology.
- Matrixed relationships particularly with Clinical Pharmacology Leads, Clinicians, Statisticians, and colleagues from Programming groups and other groups as required.
N/ANON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Relocation support available
Eligible for Relocation Package: NO
Eligible for Employee Referral Bonus: YES
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